NCT00881361

Surgery to Remove the Sentinel Lymph Node and Axillary Lymph Nodes After Chemotherapy in Treating Women With Stage II, Stage IIIA, or Stage IIIB Breast Cancer

Study Contact:

Study Phase:

PHASE2

Recruitment Status:

COMPLETED

NCT ID:

NCT00881361

Principal Investigator:

Study Type:

INTERVENTIONAL

Official Title:

A Phase II Study Evaluating the Role of Sentinel Lymph Node Surgery and Axillary Lymph Node Dissection Following Preoperative Chemotherapy in Women With Node Positive Breast Cancer (T1-4, N1-2, M0) at Initial Diagnosis

Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PURPOSE: This phase II trial is studying surgery to remove the sentinel lymph node and axillary lymph nodes after chemotherapy in treating women with stage II, stage IIIA, or stage IIIB breast cancer.

Eligibility

Eligibility Criteria:

1. ≥ 18 years old
2. ECOG/Zubrod Performance Status 0-1
3. Female. Note: Men are excluded from this study because the number of men with breast cancer is insufficient to provide a statistical basis for assessment of effects in this subpopulation of people with breast cancer.
4. Histologic diagnosis of invasive breast cancer, clinical stage T0-4 N1-2 M0 (excluding inflammatory breast cancer).
5. FNA biopsy or core needle biopsy of an axillary node documenting nodal disease at time of diagnosis and prior to preoperative chemotherapy.
6. Preoperative chemotherapy must be completed or planned for patient. NOTE: Patients enrolling on studies involving preoperative chemotherapy (through cooperative groups or institutional studies) may be eligible for this study, provided sentinel node surgery prior to preoperative chemotherapy was not required in the other studies.
7. No prior ipsilateral axillary surgery, such as excisional biopsy of lymph node(s) or treatment of hidradenitis.
8. No prior SLN surgery/excisional lymph node biopsy for pathological confirmation of axillary status.

Disease(s) and\or Condition(s)

Breast Cancer

Primary Purpose

DIAGNOSTIC

Intervention/Treatment

- Type: DRUG
- Name: systemic chemotherapy
- Description:
- Arm Group Labels: Study cohort
- Type: PROCEDURE
- Name: axillary lymph node dissection
- Description:
- Arm Group Labels: Study cohort
- Type: PROCEDURE
- Name: neoadjuvant therapy
- Description:
- Arm Group Labels: Study cohort
- Type: PROCEDURE
- Name: sentinel lymph node biopsy
- Description:
- Arm Group Labels: Study cohort
- Type: PROCEDURE
- Name: therapeutic conventional surgery
- Description:
- Arm Group Labels: Study cohort
- Type: PROCEDURE
- Name: ultrasound imaging
- Description:
- Arm Group Labels: Study cohort

Sponsor

Alliance for Clinical Trials in Oncology